Medical Device Project Manager 17235

Om jobbet

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry.

Assignment Description

We are looking for a Senior Project / Program Manager

What You Will Work On

Establish and lead a regulatory gap-closure program across multiple product areas

Translate regulatory gap analyses into structured and actionable work packages

Coordinate cross-functional execution across QA/RA, Engineering, Product, and Documentation teams

Ensure remediation activities follow Design Control requirements (ISO 13485)

Link remediation work to Change Control, CAPA processes, and DHF/DMR updates

Manage dependencies, risks, and resource constraints across multiple workstreams

Provide executive-level reporting on progress, risks, and decision points

Prepare decision materials for steering committees and leadership forums

Drive structured execution and ensure audit readiness across all activities

What You Bring / Required Qualifications

Proven experience delivering regulatory remediation, audit response, or gap-closure programs

Strong knowledge of ISO 13485 and EU MDR

Experience with FDA QSR / QMSR (preferred)

Experience working with design control processes, including retrospective remediation

Ability to coordinate across multiple products and organizational units

Experience working in cross-functional environments with QA/RA, engineering, and product teams

Strong ability to manage complex programs with multiple dependencies

Fluent in English, both written and spoken